A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
NCT ID: NCT04088500
Last Updated: 2023-01-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2020-09-03
2021-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nivolumab + Ipilimumab (combination)
Nivolumab + Ipilimumab (combination) Q3W for 4 doses
Nivolumab
Specific dose on specific days
Ipilimumab
Specific dose on specific days
Interventions
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Nivolumab
Specific dose on specific days
Ipilimumab
Specific dose on specific days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after induction with ipilimumab and nivolumab
* Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be submitted for embedded tissue block or tumor tissue.
Age and Reproduction Sexually active males with WOCBP must agree to instructions for contraception and fetal protection.
WOCBP need to use contraception throughout the study and for 5 months post treatment.
Exclusion Criteria
* Participants with an active autoimmune disease, diabetes mellitus, skin disorders, hyperthyroidism requiring hormone treatments are permitted to enroll.
* Any major surgery 28 days before 1st treatment Concomitant Therapy
* participants that have received a live vaccine within 30 days of treatment.
* use of investigational agent or device with in 28 days before first dosage study treatment.
Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and Reproduction
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Washington University School of Medicine in St. Louis WUSTL
St Louis, Missouri, United States
Local Institution
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
Atlantic Clinical Cancer Research Unit
Halifax, Nova Scotia, Canada
Hamilton Health Sciences (HHS) - Juravinski Cancer Centre (JCC)
Hamilton, Ontario, Canada
Toronto Sunnybrook Regional Cancer Ctr
Toronto, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution - 0005
Montreal, Quebec, Canada
Local Institution
Québec, Quebec, Canada
Local Institution - 0006
Sherbrooke, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-73M
Identifier Type: -
Identifier Source: org_study_id
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